Remote QA Manager

Summary

We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to an FDA project. The ideal candidate will have a strong background in regulatory compliance, particularly with FDA regulations, and will ensure that all deliverables meet the highest quality standards.

Requirements

• Bachelor’s degree in Quality Assurance, Regulatory Affairs, Life Sciences, or a related field
• Minimum of 5 years of experience in quality assurance, with a focus on FDA-regulated industries
• Proven experience managing QA teams
• Strong knowledge of FDA regulations, guidelines, and quality standards
• Excellent analytical, problem-solving, and decision-making skills
• Strong leadership and team management abilities
• Exceptional communication and interpersonal skills

Responsibilities

• Oversee the development and implementation of QA processes
• Ensure all project activities comply with FDA regulations and guidelines
• Lead and manage the QA team, providing guidance and support to ensure the team meets project goals
• Develop and execute test plans, scripts, and procedures to ensure product quality and compliance
• Conduct regular audits and reviews to ensure adherence to quality standards and regulatory requirements
• Collaborate with cross-functional teams, including Regulatory Affairs, Product Development, and Project Management, to ensure quality requirements are met
• Prepare and present QA reports and documentation
• Stay current with FDA regulations, guidelines, and best practices to ensure ongoing compliance

Preferred Qualifications

• Advanced degree in Quality Assurance, Regulatory Affairs, or a related field
• Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma)
• Experience with electronic quality management systems (eQMS)
• Familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP)

Benefits

• TestPros offers competitive salary
• TestPros offers medical/dental/vision insurance
• TestPros offers life insurance
• TestPros offers 3 weeks of paid vacation
• TestPros offers 2 weeks of paid federal holidays
• TestPros offers education/training and professional certifications
• TestPros offers a 401(k) retirement plan with up to 4% company match
• TestPros offers opportunities for professional growth and much more!